Real-world utilization of gonadotropins and the associated cumulative live birth rates in the United States: a retrospective claims database analysis

Gonadotropins approved in the United States (US) for ovarian follicle stimulation and pregnancy include follitropin alfa, follitropin beta, and Highly Purified Human Menopausal gonadotropin (HP-hMG). This study assessed the real-world utilization of these gonadotropins and associated cumulative live birth rates (CLBR) in US women with infertility. Females (age 18–42 years) who received gonadotropins after infertility diagnosis were identified from the IQVIA PharMetrics Plus database (1/2016–6/2022). Four cohorts were constructed based on the treatment on the index date (first gonadotropin use): HP-hMG monotherapy, follitropin alfa monotherapy, follitropin beta monotherapy, and mixed protocol (HP-hMG with follitropin alfa or follitropin beta). Gonadotropin utilization and incidence of ovarian hyperstimulation syndrome (OHSS) and severe OHSS were described during 2016–2021. CLBR was assessed for the first live births associated with the index gonadotropin regimen using logistic regression adjusting for baseline characteristics. Among 14,174 women, the mean age was 34.7 (SD: 4.1) years, with 47.1% <35 years. During 2016–2021, HP-hMG use in a mixed protocol (60.1–71.2%) or as monotherapy (4.3–5.7%) increased, while use of follitropin alfa (21.7–11.4%) and follitropin beta (13.9–11.6%) monotherapy decreased. Compared to follitropin alfa, the adjusted odds of live birth were significantly higher after the mixed protocol (OR [95% CI]: 1.31 [1.20–1.45]) and HP-hMG monotherapy (1.28 [1.08–1.53]); the estimate for follitropin beta versus follitropin alfa was closer to the null (0.96 [0.84–1.10]). The rate of OHSS was low across all cohorts (1.2–2.9%) and severe OHSS was rare (0.1%). As an observational analysis lacking data on key predictors of IVF success, associations should not be interpreted as comparative efficacy. In US women with infertility, HP-hMG as monotherapy or in a mixed protocol increased in use during 2016–2021 and was associated with higher odds of CLBR compared to follitropin alfa monotherapy.